RecruitingPhase 1interventionalRules rewrite

Phase 1: testing ASC35 Injection B, for subcutaneous use for Chronic Weight Management

This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection

Official registry: https://clinicaltrials.gov/study/NCT07842640 · Ascletis Pharma (China) Co., Limited · enrollment listed as 84

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ASC35 Injection B, for subcutaneous use, ASC35 Placebo Injection B, for subcutaneous use, or Tirzepatide. The registry lists allocation as randomized. This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection

They plan to enroll about 84 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight

Interventions: ASC35 Injection B, for subcutaneous use, ASC35 Placebo Injection B, for subcutaneous use, Tirzepatide

Primary outcome (registry wording): Adverse events

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
Are between 18 and 65 years of age (both inclusive) at time of screening
No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures

Who the registry excludes

Have evidence of any clinically significant active or chronic disease
Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma
Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised
Have a history of acute or chronic pancreatitis
Have a known clinically significant gastric emptying abnormality
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy
Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol

Public study contact (from the registry)

Ascletis Recruiting

+1 2068073688

clinicaltrials@ascletis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Ascletis Clinical Site — Baltimore, Maryland (recruiting)

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FAQ about this NCT record

Is NCT07842640 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07842640?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07842640?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary