CClinicalTrials.gg
Sign In
Not yet recruitingNCT07065136Updated Jul 15, 2025

Evaluation of 627 in Healthy Adult Subjects

A Phase 1 interventional study of 627 and Placebo in Healthy Subjects (HS), sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-627 in healthy adult subjects after single subcutaneous injection.

Read the detailed description

Seven dose groups are planned for dose escalation in SAD of this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S7 follow randomized, double-blinded, placebo-control design. Blood samples will be collected for PK, immunogenicity, biomarkers, laboratory tests, etc. according to the study schedule throughout the study.

02

Conditions studied

  • Healthy Subjects (HS)
03

In context

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 56 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • History of severe allergy, or with a history of allergy to the study treatment or related excipients.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    627

    Biological: 627 · Other: Placebo

  • Placebo comparator
    Placebo

    Biological: 627 · Other: Placebo

Interventions

  • Biological627

    subcutaneous injection

  • OtherPlacebo

    Single subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Number of participants with Adverse Events

    Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.

    Time frame: D99

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07065136
Lead sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Responsible party
Sponsor
First posted
Jul 15, 2025
Start date
Jul 20, 2025 (estimated)
Primary completion
Sep 18, 2026 (estimated)
Completion
Sep 18, 2026 (estimated)
Last update
Jul 15, 2025

Study contacts

zhou
Contact
zhouqinghong@3sbio.com
021-8029 7777

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Start the discussion