G03-52-01 Safety and Efficacy Study for Healthy Subjects

Recruiting at 14 trial locations

Overseen By Angie Kimbler

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Resilience Government Services, Inc.

Must not be taking: H1 antihistamines, Beta-blockers, Immunosuppressives, others

Disqualifiers: Diabetes, Hypertension, Autoimmune disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 45 days

625 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like H1 antihistamines, beta-blockers, and some immunosuppressive drugs are prohibited close to dosing days, so you may need to adjust your medication schedule.

What safety data exists for the treatment G03-52-01 in humans?

The research articles reviewed do not provide specific safety data for the treatment G03-52-01 in humans. They discuss general safety assessment methods and placebo effects, but no direct information on G03-52-01. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a medication called G03-52-01 given as an injection into the muscle. It involves adult participants and will assess the effects of the medication over time.

Eligibility Criteria

Healthy adults aged 18-65 with a BMI of 18.5 to 35 kg/m2 can join this trial. Women must not be pregnant or breastfeeding and should use effective contraception if of childbearing potential. Participants must have normal lab results, no drug abuse, and agree to avoid vigorous activity around dosing days.

Inclusion Criteria

Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2

Informed consent understood and signed prior to screening procedures

I am not of childbearing potential due to menopause or surgery.

Exclusion Criteria

I have not had, nor plan to have, any botulinum toxin injections for any reason in the 4 months around joining.

Clinically significant abnormal electrocardiogram (ECG) at screening. Clinically significant abnormal ECG results include but not limited to complete left or right bundle branch block; other ventricular conduction block except for incomplete RBB; 2nd degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern of ST elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator

Is currently participating or has participated in a study with an investigational product (IP) within 28 days preceding Day 1 (documented receipt of placebo in a previous trial would be permissible for trial eligibility)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single or repeat dose of G03-52-01 administered by IM injection

45 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

240 days

Regular visits for safety assessments and monitoring

Treatment Details

Interventions

• G03-52-01
• Placebo

Trial Overview The study is testing G03-52-01 against a placebo in healthy volunteers. It's a Phase 2 trial where participants are randomly assigned to receive either the test drug or an inactive substance (placebo), but neither they nor the researchers know who gets which one.

Participant Groups

Group I: 50 mg dose of G03-52-01 Experimental Treatment 1 Intervention

150 subjects randomized to 50 mg of G03-52-01

Group II: 100 mg dose of G03-52-01 or Placebo Experimental Treatment 2 Interventions

250 subjects randomized to 100 mg of G03-52-01 or placebo

Group III: 100 mg dose of G03-52-01 Experimental Treatment 1 Intervention

150 subjects randomized to 100 mg of G03-52-01

Group IV: Placebo Placebo Group 1 Intervention

75 subjects randomized to placebo

Who Is Running the Clinical Trial?

Resilience Government Services, Inc.

Lead Sponsor

Trials

38

Recruited

32,700+

Ology Bioservices

Lead Sponsor

Trials

37

Recruited

32,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

Adverse events (AEs) are reported in 49.1% of trial participants in placebo groups, indicating that these events are quite common and not solely due to the natural progression of conditions.

The prevalence of AEs in placebo groups (6.51%) is higher than in untreated groups (4.25%), suggesting that the nocebo effect may play a significant role in the experience of AEs during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Howick, J., Webster, R., Kirby, N., et al.[2022]

The study introduces a new method for determining the maximum safe dose (MAXSD) in clinical trials, focusing on identifying the highest dose that does not significantly increase safety risks compared to a placebo.

This approach emphasizes controlling false-negative errors in safety assessments, which is crucial for ensuring that potentially harmful doses are not mistakenly deemed safe, thereby improving the reliability of dose-finding studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the maximum safe dose: a multiple testing approach. Hothorn, LA., Hauschke, D.[2014]

Nonclinical studies are essential for assessing the safety of new vaccines, focusing on various aspects such as single dose toxicity, local tolerance, repeat dose toxicity, and safety pharmacology, to support clinical development and licensure.

The design of these studies must be tailored to the vaccine's intended use, including factors like patient population and administration route, ensuring that the test item closely resembles the clinical formulation for accurate safety evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study designs for the nonclinical safety testing of new vaccine products. Forster, R.[2012]

References

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

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]

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

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Identifying the maximum safe dose: a multiple testing approach. [2014]

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

How important are concurrent vehicle control groups in (sub)chronic non-human primate toxicity studies conducted in pharmaceutical development? An opportunity to reduce animal numbers. [2023]

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

Study designs for the nonclinical safety testing of new vaccine products. [2012]