AFA-281 Safety Study in Healthy Volunteers

Overseen By Dennis Gilman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Afasci Inc

Disqualifiers: Significant medical history, others

Compensation: Varies

Number of Visits: 72

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, AFA-281, in healthy volunteers to check its safety and how it behaves in the body. Volunteers take the drug for a short period. Researchers measure drug levels in the blood and monitor for any side effects.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial is for healthy volunteers with no significant medical history, it's likely that participants should not be on any regular medications.

Will I have to stop taking my current medications?

The trial is for healthy volunteers with no significant medical history, which suggests that participants should not be on any current medications. The protocol does not specify a requirement to stop taking medications, but it implies that participants should not be taking any.

What data supports the idea that AFA-281 Safety Study in Healthy Volunteers is an effective treatment?

The available research does not provide any specific data or evidence supporting the effectiveness of AFA-281 Safety Study in Healthy Volunteers as a treatment. The articles focus on other topics such as patient outcomes after femoral neck fracture, patient willingness to question healthcare staff, adverse events in hospitalized patients, and quality improvement in radiation oncology. None of these studies directly address the effectiveness of AFA-281. ^{1 2 3 4 5}

What existing safety data is available for AFA-281?

The provided research does not specifically mention AFA-281 or its safety data. However, it discusses general safety data from phase I studies involving healthy volunteers, including adverse events and safety assessments in early drug development. These studies highlight the importance of monitoring adverse events and using microdose studies to improve safety assessments in early drug trials. ^{6 7 8 9 10}

Is the drug AFA-281 a promising treatment?

Yes, AFA-281 is a promising drug because early human volunteer studies can help assess its safety and effectiveness quickly, reducing the need for animal testing and improving the selection of successful drug candidates. ^{7 8 10 11 12}

What makes the drug AFA-281 unique compared to other treatments?

AFA-281 is being tested in healthy volunteers in a Phase I trial, which is an early stage of drug development focusing on safety and metabolism in humans. This approach can help reduce animal testing and provide early human data on how the drug is processed in the body, potentially leading to more efficient drug development. ^{7 8 10 11 12}

Research Team

Xinmin Xie, MD, PhD

Principal Investigator

Afasci Inc

Eligibility Criteria

This trial is for healthy volunteers with a BMI between 18.0 and 30.0, no significant medical history, normal lab values, and a normal ECG. People with any significant health issues or abnormal test results cannot participate.

Inclusion Criteria

Your heart test (ECG) should not show any important problems.

Your body mass index (BMI) must be between 18.0 and 30.0 kg/m2.

I am in good health with no major medical issues.

Exclusion Criteria

You have significant abnormal medical conditions.

You have abnormal results on an ECG test.

Participants with significant medical history or clinically significant abnormalities

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Part 1: Single Ascending Dose

Healthy volunteers receive a single ascending dose of AFA-281 or placebo. Safety, tolerability, and pharmacokinetics are evaluated.

1 week

Daily visits for up to 72 hours post-dose

Phase I Part 2: Multiple Ascending Doses

Pending results from Part 1, volunteers receive multiple doses of AFA-281 or placebo for 14-21 days. Safety, tolerability, and pharmacokinetics are evaluated.

2-3 weeks

Routine clinical monitoring throughout the dosing period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AFA-281

Trial Overview The study tests AFA-281 in two parts: Part 1 gives single doses to groups of volunteers to check safety and how the body processes the drug. If safe, Part 2 has them take it for 14 days to further assess these factors.

Participant Groups

Group I: AFA-281 Experimental Treatment 1 Intervention

Part 1: AFA-281 administered as an oral capsule at 5 dose levels for one day. Part 2: AFA-281 administered as an oral capsule at 3 dose levels twice daily for 14 consecutive days. Doses will be determined after completion of Part 1.

Group II: Placebo Control Placebo Group 1 Intervention

Double blind placebo control

Who Is Running the Clinical Trial?

Afasci Inc

Lead Sponsor

Trials

4

Recruited

490+

Cognitive Research Corporation

Industry Sponsor

Trials

25

Recruited

2,400+

Findings from Research

In a study of 182 patients aged 20-69 with femoral neck fractures treated with internal fixation, 73% of those with displaced fractures and 85% with non-displaced fractures reported good or excellent functional outcomes at 24 months.

Despite a significant percentage achieving good functional outcomes, patients did not fully regain their pre-fracture health-related quality of life, indicating that while surgical intervention is effective, it may not restore overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. Campenfeldt, P., Hedström, M., Ekström, W., et al.[2018]

Surgical patients are significantly more willing to ask factual questions about their care than challenging questions, indicating a need for strategies to empower patients to engage more actively in their healthcare.

Patients who received instructions from doctors were more likely to ask challenging questions, suggesting that healthcare staff can play a crucial role in encouraging patient involvement in safety discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How willing are patients to question healthcare staff on issues related to the quality and safety of their healthcare? An exploratory study. Davis, RE., Koutantji, M., Vincent, CA.[2022]

In a study of 100 hospitalized flu patients (50 in isolation and 50 not), the incidence of adverse events (AEs) was found to be lower in those undergoing isolation measures, with significant differences in AE identification based on the observer's definition of a case.

The study highlighted the importance of inter-observer agreement in identifying AEs, showing good agreement for screening (over 76% Kappa index) but lower agreement for accurately identifying AEs related to care, indicating that methodology is crucial for reliable epidemiological studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Identification of adverse events in hospitalised influenza patients]. Aranaz-Andrés, JM., Gea-Velázquez de Castro, MT., Jiménez-Pericás, F., et al.[2017]

A study involving 134 patients found that 90% rated the animated video on patient safety as good or very good, while 100% of those receiving oral information felt the same, indicating high satisfaction with both methods.

Despite the positive feedback for the video, 74% of patients who received both formats preferred the oral presentation, suggesting that while videos can enhance understanding, they should not replace traditional verbal communication for optimal patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating Patient Safety Information Through Video and Oral Formats-A Comparison. Bånnsgård, M., Nouri, A., Finizia, C., et al.[2023]

A quality improvement initiative at the Center for Cancer Care tracked adverse outcomes in 91 patients receiving radiotherapy, revealing that 54.9% experienced treatment-related toxicity and 21.1% died during or shortly after treatment.

The study found that advanced age was linked to poorer overall and disease-free survival, indicating that healthcare providers should pay special attention to elderly patients undergoing radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality improvement program in radiation oncology: understanding patient hospitalizations, treatment breaks, and weight loss in patients receiving radiotherapy. Chowdhry, V., Jangro, P., Goldberg, S., et al.[2019]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

The workshop highlighted the potential of using very low dose human studies (microdoses) to assess drug candidates earlier in the development process, which could improve the selection of effective drugs while ensuring volunteer safety.

Incorporating advanced techniques like accelerator mass spectrometry (AMS) and positron emission tomography (PET) in these early human studies could provide valuable data on how drugs are processed in the body, potentially reducing reliance on animal testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing. Combes, RD., Berridge, T., Connelly, J., et al.[2019]

In a review of 24 First-in-Man studies involving 1,017 healthy male volunteers, the incidence of adverse events (AEs) was low, with 98.3% of AEs being mild or moderate, indicating a favorable safety profile for small molecules in Phase I trials.

Only 0.4% of treatments resulted in serious adverse events, all of which were not medically concerning and did not require hospitalization, suggesting that small molecule trials can be conducted safely in healthy volunteers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. Wensing, G., Ighrayeb, IA., Boix, O., et al.[2019]

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

Human volunteer studies are crucial for gathering data on the biokinetics and metabolism of compounds, which is essential for accurate human risk assessment.

These studies can enhance the reliability of extrapolating results from animal studies to humans, helping to fill knowledge gaps that in vitro or animal studies cannot address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in toxicology. Meulenbelt, J., Mensinga, TT., Kortboyer, JM., et al.[2019]

In a study involving 2990 potential volunteers across seven African sites, 2387 (80%) were enrolled, but only 2107 (71%) were included in the final analysis due to various health-related exclusions, highlighting the importance of health screening in clinical trials.

The study found that a significant number of volunteers were excluded from analysis due to positive tests for Hepatitis B and C, as well as abnormal physical examination findings, indicating the need for tailored health assessments in African populations participating in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials. Stevens, W., Kamali, A., Karita, E., et al.[2022]

In a study of 120 healthy young adults, the intrinsic extension reserve (IER) of the hip joint was found to vary significantly among different sagittal alignment subtypes, indicating that spinal alignment can influence hip extension capacity.

The study revealed that individuals with a greater sacral slope had a higher range of motion in both the pelvis and hip joint, suggesting that pelvic alignment may play a crucial role in hip extension mechanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip-Spine Relationship between Sagittal Balance of the Lumbo-Pelvi-Femoral Complex and Hip Extension Capacity: An EOS Evaluation in a Healthy Caucasian Population. Kouyoumdjian, P., Mansour, J., Haignère, V., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. [2018]

2. England pubmed.ncbi.nlm.nih.gov

How willing are patients to question healthcare staff on issues related to the quality and safety of their healthcare? An exploratory study. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

[Identification of adverse events in hospitalised influenza patients]. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Communicating Patient Safety Information Through Video and Oral Formats-A Comparison. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Quality improvement program in radiation oncology: understanding patient hospitalizations, treatment breaks, and weight loss in patients receiving radiotherapy. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in toxicology. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Hip-Spine Relationship between Sagittal Balance of the Lumbo-Pelvi-Femoral Complex and Hip Extension Capacity: An EOS Evaluation in a Healthy Caucasian Population. [2023]