Alzheimer's DiseasePhase 1NCT07889349
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR 3201 Injection in Healthy Participants
A Phase 1 study testing SHR 3201 Injection in people with Alzheimer's Disease, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This study is a randomized, double-blind, dose-escalation, placebo-controlled Phase I clinical trial in healthy participants to evaluate the safety, tolerability, and pharmacokinetics of single intravenous and subcutaneous administrations of SHR-3201. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- SHR 3201 Injection
- 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
- Nov 2026to Feb 2027
- Phase
- Phase 1
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants aged 18 to 60 years (inclusive) at the time of informed consent signing;
- Male participants weighing ≥ 50.0 kg, and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²);
- Female participants of child bearing potential shall agree to contraception and oocyte donation avoidance from ICF signature to 6 months after last investigational product dose, with negative serum pregnancy tests at screening and baseline. Male participants shall agree to highly effective contraception and sperm donation avoidance from ICF signature to 6 months after last investigational product dose;
- Ability to understand the study procedures and requirements, willingness to participate voluntarily, and provide written informed consent.
Who cannot join
- Participants with past or current acute or chronic disorders of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric systems or metabolic abnormalities, as assessed by the Investigator to be unsuitable for study enrollment;
- Have a history of drug or other allergies, or, in the investigator's judgment, may be allergic to the investigational product or any of its components;
- Have undergone major surgery within 6 months prior to screening, or have undergone surgery that may significantly affect the in vivo disposition of the investigational product or the safety evaluation, or plan to undergo surgery during the trial period;
- Have participated in any clinical trial as a participant within 3 months prior to Screening, or plan to participate in other clinical trials during the course of this study;
- Have experienced blood loss or donated blood > 400 mL (excluding menstrual blood loss in females), received blood transfusion or blood products within 3 months prior to Screening, or plan to donate blood during the trial or within 1 month after the end of the trial;
- Cannot tolerate MRI or have MRI contraindications, including but not limited to cardiac pacemaker, defibrillator, artificial heart valve or other metallic implants; or other conditions assessed by the Investigator that may cause potential risks during MRI scanning;
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- Have any laboratory abnormalities at screening, or have clinically significant abnormalities in vital signs, physical examinations, or laboratory tests specified in the protocol as judged by the investigator;
- Have chest X-ray (posteroanterior view) or abdominal ultrasound findings at Screening judged by the investigator to be clinically significant abnormalities;
- Have positive results at Screening for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), or Treponema pallidum antibody (Anti-TP);
- Have used or are currently using any prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to dosing; or have taken functional vitamins, health supplements, or herbal products; or are known to require other medication during the trial period;
- Have consumed excessive amounts of tea, coffee, or caffeinated beverages (average > 8 cups per day, 200 mL per cup) within 3 months prior to screening;
- Have consumed special foods (e.g., grapefruit, grapefruit juice, or food/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeinated products, etc.) within 48 hours prior to dosing;
- Have a history of regular alcohol consumption (i.e., > 14 standard units per week within 3 months prior to Screening, where 1 standard unit contains 14 g of alcohol, equivalent to 285 mL of beer, 25 mL of 40% spirit, or 85 mL of wine), or are unable to abstain from alcohol during the trial; or have a positive alcohol breath test;
- Have an average daily smoking history of > 5 cigarettes per day within 3 months prior to Screening, or are unable to abstain from smoking during the trial;
- Have a history of drug abuse or substance use; or have a positive result on drug abuse screening (including MDMA, methamphetamine, morphine, ketamine, and THC acid);
- Are pregnant or lactating females;
- Have difficulty with venous blood sampling, are unable to tolerate venipuncture, or have a history of needle or blood phobia;
- Participants who, in the opinion of the investigator, may be unable to complete the study for other reasons, or who are considered unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000
Jiong Shi, jshi2022@ustc.edu.cn
Zhaoyi Yang, +86-0551-65997421, young2382@ustc.edu.cn
About this study
Official title: A Randomized, Double Blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Subcutaneous Administrations of SHR 3201 Injection in Healthy Participants
This study is a randomized, double-blind, dose-escalation, placebo-controlled Phase I clinical trial in healthy participants to evaluate the safety, tolerability, and pharmacokinetics of single intravenous and subcutaneous administrations of SHR-3201.
- Conditions
- Alzheimer's Disease
- Being tested
- SHR 3201 Injection, SHR 3201 Placebo.
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR 3201 InjectionDrug
SHR 3201 injection.
SHR 3201 Placebo.Drug
SHR 3201 placebo.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 Group: SHR-3201 + Placebo | Experimental | SHR-3201, SHR-3201 Placebo. Receives: Drug: SHR 3201 Injection; Drug: SHR 3201 Placebo. |
| Dose 2 Group: SHR-3201 + Placebo | Experimental | SHR-3201, SHR-3201 Placebo. Receives: Drug: SHR 3201 Injection; Drug: SHR 3201 Placebo. |
| Dose 3 Group: SHR-3201 + Placebo | Experimental | SHR-3201, SHR-3201 Placebo. Receives: Drug: SHR 3201 Injection; Drug: SHR 3201 Placebo. |
| Dose 4 Group: SHR-3201 + Placebo | Experimental | SHR-3201, SHR-3201 Placebo. Receives: Drug: SHR 3201 Injection; Drug: SHR 3201 Placebo. |
| Dose 5 Group: SHR-3201 + Placebo | Experimental | SHR-3201, SHR-3201 Placebo. Receives: Drug: SHR 3201 Injection; Drug: SHR 3201 Placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: From pre-dose to 36 days post-dose.
Secondary outcomes (9)
Serum concentration of SHR-3201 after single-dose administration
Measured: From pre-dose to 29 days post-dose.
Area Under the Concentration (AUC) of SHR-3201 after single administration (AUC0-last, AUC0-inf)
Measured: From pre-dose to 29 days post-dose.
Time to peak concentration (Tmax)
Measured: From pre-dose to 29 days post-dose.
Peak concentration (Cmax)
Measured: From pre-dose to 29 days post-dose.
Elimination half-life (T1/2)
Measured: From pre-dose to 29 days post-dose.
Clearance (CL)
Measured: From pre-dose to 29 days post-dose.
Steady-state volume of distribution (Vss)
Measured: From pre-dose to 29 days post-dose.
Bioavailability of SHR-3201 following subcutaneous administration
Measured: From pre-dose to 29 days post-dose.
Incidence of anti-drug antibodies (ADA)
Measured: From pre-dose to 29 days post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- Randomized, double-blind, dose-escalation, placebo-controlled Phase I clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889349
- Sponsor's protocol ID
- SHR-3201-101
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided