Healthy Subjects (HS)Phase 1NCT06674525
Evaluation of 626 in Healthy Adult Subjects
A Phase 1 study testing 626 in people with Healthy Subjects (HS), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- 626
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2024to 28 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
Read the detailed description
Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 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.
- Conditions
- Healthy Subjects (HS)
- Being tested
- 626, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
626Drug
Also called SSGJ-626
Single subcutaneous injection
PlaceboDrug
Single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 626 Group S1 for subcutaneous injection | Experimental | dose level 1 of 626 Receives: Drug: 626; Drug: Placebo |
| 626 Group S2 for subcutaneous injection | Experimental | dose level 2 of 626 Receives: Drug: 626; Drug: Placebo |
| 626 Group S3 for subcutaneous injection | Experimental | dose level 3 of 626 Receives: Drug: 626; Drug: Placebo |
| 626 Group S4 for subcutaneous injection | Experimental | dose level 4 of 626 Receives: Drug: 626; Drug: Placebo |
| 626 Group S5 for subcutaneous injection | Experimental | dose level 5 of 626 Receives: Drug: 626; Drug: Placebo |
| 626 Group S6 for subcutaneous injection | Experimental | dose level 6 of 626 Receives: Drug: 626; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (4)
Cmax
Peak concentration (Cmax) will be calculated.
Measured: 90 days
Tmax
Time to peak concentration (Tmax) will be calculated.
Measured: 90 days
AUC0-last
Area under the concentration-time curve from time 0 to the time point of last measurable concentration post-dose (AUC0-last) will be calculated.
Measured: 90 days
Incidence of Anti-Drug Antibody
Anti-drug antibody (ADA) positive rate and titer will be calculated. Incidence of neutralizing antibody (Nab) if ADA is positive.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start2 Dec 2024
- Primary completion13 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674525
- Sponsor's protocol ID
- SSGJ-626-HV-I-01
- Status last verified
- Dec 2025
- First submitted
- 1 Nov 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06674525
- Acronym / sponsor ID
- SSGJ-626-HV-I-01
- Conditions
- Healthy Subjects (HS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
Detailed description
Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 626 Group S1 for subcutaneous injection | Experimental | Drug: 626, Drug: Placebodose level 1 of 626 |
| 626 Group S2 for subcutaneous injection | Experimental | Drug: 626, Drug: Placebodose level 2 of 626 |
| 626 Group S3 for subcutaneous injection | Experimental | Drug: 626, Drug: Placebodose level 3 of 626 |
| 626 Group S4 for subcutaneous injection | Experimental | Drug: 626, Drug: Placebodose level 4 of 626 |
| 626 Group S5 for subcutaneous injection | Experimental | Drug: 626, Drug: Placebodose level 5 of 626 |
| 626 Group S6 for subcutaneous injection | Experimental | Drug: 626, Drug: Placebodose level 6 of 626 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 626Also: SSGJ-626Single subcutaneous injection | Drug | 626 Group S1 for subcutaneous injection, 626 Group S2 for subcutaneous injection, 626 Group S3 for subcutaneous injection, 626 Group S4 for subcutaneous injection, 626 Group S5 for subcutaneous injection, 626 Group S6 for subcutaneous injection |
| PlaceboSingle subcutaneous injection | Drug | 626 Group S1 for subcutaneous injection, 626 Group S2 for subcutaneous injection, 626 Group S3 for subcutaneous injection, 626 Group S4 for subcutaneous injection, 626 Group S5 for subcutaneous injection, 626 Group S6 for subcutaneous injection |
Primary outcome
Number of participants with Adverse Events
Time frame: 90 days
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.
4 secondary outcomes
Cmax
Time frame: 90 days
Tmax
Time frame: 90 days
AUC0-last
Time frame: 90 days
Incidence of Anti-Drug Antibody
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 626 in people with Healthy Subjects (HS), run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.