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AFA-281 Safety Study in Healthy Volunteers

Phase 1

Recruiting

Research Sponsored by Afasci Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be in good general health with no significant medical history and have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of study drug.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours after dose

Awards & highlights

Study Summary

This trial will test the safety & tolerability of a new drug in healthy volunteers, & measure levels of the drug in the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is an early-phase trial for AFA-281, potential side effects are being investigated; however, common side effects may include reactions at the dosing site, gastrointestinal discomforts like nausea or diarrhea, headaches or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am in good health with no major medical issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and up to 72 hours after dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and up to 72 hours after dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and up to 72 hours after dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration versus time curve (AUC) of the study drug

Blood Pressure

Blood chemistry

+9 more

Secondary outcome measures

A dose and exposure relationship

Area under the plasma concentration versus time curve (AUC) of the major metabolite in blood

Plasma Concentration (Cmax) of the major metabolite in blood

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AFA-281Experimental Treatment1 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 ControlPlacebo Group1 Intervention

Double blind placebo control

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Afasci IncLead Sponsor

Xinmin Xie, MD, PhDStudy ChairAfasci Inc

Simon Xie, MD, PhDStudy ChairAfasci Inc

Media Library

AFA-281 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05547503 — Phase 1

Inflammatory Pain Research Study Groups: AFA-281, Placebo Control

Inflammatory Pain Clinical Trial 2023: AFA-281 Highlights & Side Effects. Trial Name: NCT05547503 — Phase 1

AFA-281 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547503 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accept participants aged 45 and over?

"Those hoping to enrol in this clinical trial must be between 18 and 65 years old. There are 58 studies for people beneath the age of majority, while 583 trials cater specifically to those over retirement age."

Answered by AI

Is this investigation currently accepting new participants?

"Yes, information on clinicaltrials.gov confirms that this medical study is currently recruiting candidates. It was posted on April 22nd 2023 and has been revised as recenty as July 18th 2023. The trial requires 64 participants from one site to take part in the experiment."

Answered by AI

What is the current regulatory status of AFA-281?

"Our team at Power has assigned AFA-281 a safety score of 1 due to the limited evidence presented in the Phase 1 trial, which provides inadequate data on both efficacy and security."

Answered by AI

Who qualifies to enter this research program?

"The present clinical trial is seeking 64 individuals of legal age with a diagnosis of osteoporosis. Applicants should be in good physical health, have normal laboratory values, and have no clinically relevant ECG abnormalities. Additionally, participants must possess a BMI between 18.0 - 30.0 kg/m2 inclusive to qualify for enrollment."

Answered by AI

How many participants are included in this clinical exploration?

"Correct. According to the information hosted on clinicaltrials.gov, this medical study is currently recruiting candidates; it was initially posted on April 22nd 2023 and most recently updated on July 18th 2023. 64 people are needed from 1 site in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Single Ascending Dose and Multiple Ascending Doses of Oral AFA-281 in Healthy Volunteers

2023. "Phase I Single Ascending Dose and Multiple Ascending Doses of Oral AFA-281 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547503.

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