A Study to Evaluate Single Doses of Alpha-0261 in Healthy Adult Volunteers

December 10, 2025 updated by: AlphaMol Science Ltd. (Shanghai)

A Randomized, Double-blind, Placebo-Controlled, Dose-Escalation, Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Administration of Alpha-0261 Tablets in Adult Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Alpha-0261 tablets after single oral administration in healthy adult volunteers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Bishan Hospital of Chongqing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged ≥ 18 and ≤ 55, male or female
  • Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2
  • In general good health

Exclusion Criteria:

  • Have a history of any severe allergic reaction or anaphylaxis
  • Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol
  • Have clinically significant abnormalities on clinical laboratory results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Ascending Dose
Drug: Alpha-0261
Oral, tablet
Placebo Comparator: Single Ascending Dose (placebo)
Other: Placebo
Oral, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of treatment emergent adverse events
Time Frame: From enrollment to end of follow-up visit, up to approximately 1 week
From enrollment to end of follow-up visit, up to approximately 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma PK of Alpha-0261 after single dose
Time Frame: From enrollment to end of treatment period, up to approximately 7 days
Maximum Plasma Concentration (Cmax)
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
Time Frame: From enrollment to end of treatment period, up to approximately 7 days
Elimination half life (T 1/2)
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
Time Frame: From enrollment to end of treatment period, up to approximately 7 days
Area Under the Concentration-time Curve (AUC)
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
Time Frame: From enrollment to end of treatment period, up to approximately 7 days
Time to Reach The Maximum Plasma Concentration (Tmax)
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
Time Frame: From enrollment to end of treatment period, up to approximately 7 days
Apparent Systemic Clearance (CL/F)
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
Time Frame: From enrollment to end of treatment period, up to approximately 7 days
Apparent Volume of Distribution (Vz/F)
From enrollment to end of treatment period, up to approximately 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlphaMol Science Ltd. (Shanghai)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2025

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Alpha-0261-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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