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First human test of SSGJ-626: will it be safe?

NCT ID NCT06674525

Knowledge-focused Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This early-stage trial tests a single injection of the experimental drug SSGJ-626 in healthy adults aged 18 to 45. The main goal is to check for side effects and see how the drug moves through the body. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor the researchers know who gets what. The results will help decide whether further studies in patients are possible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SSGJ-626
What this could lead to
If safe, this could pave the way for future studies of SSGJ-626 in specific diseases.
What could go wrong
This is an early Phase 1 trial in healthy people, so it cannot yet show whether the drug works for any condition. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to understand protocol requirements and sign a written ICF. * Male or female subjects aged 18-45 years when signing the ICF. * Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m2. * Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator. * Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures. Exclusion Criteria: * History of severe allergy, or with a history of allergy to the study treatment or related excipients. * With any clinically significant diseases prior to the screening visit. * Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody. * History of of significant alcohol abuse. * History of significant drug abuse. * Subjects who have positive result for urine nicotine test at screening. * Pregnant, or nursing females.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy subjects (HS)

Contacts and locations

Locations

  • Shanghai General Hospital

    Shanghai, 200080, China

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