Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..

Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Study ID
NCT07408908
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • ACT100 Injection — DRUG
    a single 5-mg subcutaneous injection
  • Placebo for ACT100 — DRUG
    a single 5-mg subcutaneous injection
  • ACT100 Injection — DRUG
    a single 25-mg subcutaneous injection
  • Placebo for ACT100 — DRUG
    a single 25-mg subcutaneous injection
  • ACT100 Injection — DRUG
    a single 100-mg subcutaneous injection
  • Placebo for ACT100 — DRUG
    a single 100-mg subcutaneous injection
  • ACT100 Injection — DRUG
    a single 300-mg subcutaneous injection
  • Placebo for ACT100 — DRUG
    a single 300-mg subcutaneous injection
  • ACT100 Injection — DRUG
    a single 600-mg subcutaneous injection
  • Placebo for ACT100 — DRUG
    a single 600-mg subcutaneous injection
  • ACT100 Injection — DRUG
    a single 800-mg subcutaneous injection
  • Placebo for ACT100 — DRUG
    a single 800-mg subcutaneous injection

Study Details

This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in healthy participants. A total of 6 dose cohorts are planned, with each cohort enrolling 8 participants (including both male and female participants, where 6 will receive the investigational drug and 2 will receive placebo). The total planned enrollment is 48 healthy participants.

Key Dates

First listed
Feb 13, 2026
Start date
Mar 6, 2026
Status verified
Feb 2026
Primary completion
Mar 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ACT100 Cohort 1
  • Placebo Comparator: Placebo Group for Cohort 1
  • Experimental: ACT100 Cohort 2
  • Placebo Comparator: Placebo Group for Cohort 2
  • Experimental: ACT100 Cohort 3
  • Placebo Comparator: Placebo Group for Cohort 3
  • Experimental: ACT100 Cohort 4
  • Placebo Comparator: Placebo Group for Cohort 4
  • Experimental: ACT100 Cohort 5
  • Placebo Comparator: Placebo Group for Cohort 5
  • Experimental: ACT100 Cohort 6
  • Placebo Comparator: Placebo Group for Cohort 6

Primary Outcome Measure

Adverse Event(AE) [ Time Frame: Day 1-84 ]

Central Contacts

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