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NCT06427590CompletedPhase 1

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects

Source: ClinicalTrials.gov · Last updated 11 May 2025

Brief summary (registry, in English)

This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period. This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
28 (actual)
First submitted
10 May 2024
Start date
13 Jul 2024
Primary completion date
31 Dec 2024
Lead sponsor
Ascletis Pharma (China) Co., Limited
Diseases
Obesity
NCT number
NCT06427590

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 28
  • From 13 Jul 2024 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have a history of febrile illness within 14 days prior to screening.
  • Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.

Other illness

  • Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
  • Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
  • Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
  • Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.

Lab values

  • Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.

Who the study is looking for

  • Subject have provided informed consent before initiation of any study-specific procedures
  • Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
  • Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ascletis
Coordinator of this site? Confirm its status
HerstonAustraliaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.