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OpenTrials
Completed

NCT Number: NCT07279636

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bishan Hospital of Chongqing

Chongqing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha-0261

Drug

Oral, tablet

Placebo

Other

Oral, tablet

Primary outcomes

  1. Frequency of treatment emergent adverse events

    Time frame: From enrollment to end of follow-up visit, up to approximately 1 week

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

AlphaMol Science Ltd. (Shanghai)

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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