Healthy SubjectPhase 1NCT04941313
Phase 1 Study of 3D229 in Healthy Subjects
A Phase 1 study testing 3D229 in people with Healthy Subject, run by 3D Medicines at 1 site in China.
Trial summary
This is a Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- 3D229
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2021to 21 Feb 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects had no clinically significant condition or disease confirmed by medical history, medical assessment, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) at screening and on the day prior to the first study drug administration;
- Male or female, aged 18-55 years at the time of signing the informed consent form;
- Body mass index (BMI) between 18 and 30 kg/m 2 (Containing 18 and 30 kg/m 2 ) within range;
- Negative urine drug screen/alcohol breath test at screening and 1 day prior to first study drug administration;
- Has not used tobacco products (including nicotine patches/gum) within 3 months prior to screening and agrees to avoid such products throughout the study;
- Complete abstinence for at least 14 days prior to the first dose of study drug and Take effective contraceptive measures within 3 months after the last dose(including Complete abstinence、 barrier contraception and completed sterilization operation), no fertility, sperm donation, egg donation program
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- If the subject is female, the serum pregnancy test at screening and urine pregnancy test on the day before first dose should be negative;
- Ability to fully read, understand and sign the informed consent form;
- Ability to communicate adequately with the investigator and to comply with the requirements of the entire study.
Who cannot join
- Blood pressure ≥ 140/90 mmHg or pulse > 100 beats/min at rest at screening;
- QT interval corrected for heart rate using Fridericia ' s formula (QTcF) > 430 msec (males) and > 450 msec (females) at screening;
- Pregnant or lactating women;
- Males with partners in pregnancy;
- Concurrently enrolled in another clinical trial, or received any study drug within 3 months prior to the first dose (or 5 drug half-lives, whichever is longer);
- Subject has a history of drug or alcohol abuse or dependence within the past 1 year;
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- Use of any prescription or over-the-counter medications, including analgesics, hormonal contraceptives (oral contraceptives or implanted contraceptives), natural food supplements, or dietary/herbal supplements (including vitamins), 14 days or 5 drug half-lives, whichever is longer;
- Donation of more than 200 mL of blood within 56 days prior to the first dose, or planned to donate blood during the study until 1 month after completion of the study;
- Hepatitis B virus (HBV) surface antigen, hepatitis C virus antibody (HCV), or human immunodeficiency virus (HIV) test results are currently or ever positive;
- Prior or current condition that, in the opinion of the investigator, may affect the conduct of the study or observations (to be confirmed by medical history);
- History or current patient ' s clinically significant disease,Including but not limited to: active tuberculosis, asthma, angioedema, bronchospasm, ulcerative disease, gastrointestinal hemorrhage, coagulation disorder, hypertension, edema, heart failure, hypokalemia, hyperkalemia, cardiovascular disease, hypersensitivity to any biological agent, and significant impact on immune responseSevere skin diseases or other conditions of the force;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and Tolerability of 3D-229 by Intravenous Single Dose Escalation and Repeated Doses in Healthy Subjects
This is a Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects
Read the detailed description
A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 by Intravenous Single Dose Escalation(SAD) and Repeated Doses(RD) in Healthy Subjects. A SAD portion of the study consists of 2 sequential dose escalation cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses of 3D229. In both SAD and RD study arms, subjects are randomized to receive either a study intervention (3D229) or matching placebo.
- Conditions
- Healthy Subject
- Being tested
- 3D229, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D229Drug
3D229 is an investigational drug.
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Escalation-3D229 | Experimental | two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo Receives: Drug: 3D229 |
| Single Dose Escalation- placebo | Placebo comparator | two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo Receives: Other: Placebo |
| Repeat Dose-3D229 | Experimental | Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo Receives: Drug: 3D229 |
| Repeat Dose-placebo | Placebo comparator | Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of 3D229-Adverse events
Monitoring of adverse events
Measured: Up to 7 weeks
Secondary outcomes (9)
AUC
Area under the curve
Measured: Up to 7 weeks
Cmax
Maximum observed concentration
Measured: Up to 7 weeks
Ctrough
Serum concentration observed at end of a single dose and observed pre-dose during repeat doses
Measured: Up to 7 weeks
Tmax
Time to reach maximum observed plasma concentration
Measured: Up to 7 weeks
λz
Terminal phase elimination rate constant
Measured: Up to 7 weeks
t1/2
Terminal half-life
Measured: Up to 3 weeks
CL
The total body clearance
Measured: Up to 7 weeks
V
Volume of distribution
Measured: Up to 7 weeks
serum GAS6
evaluate the serum GAS6 level
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start27 Jul 2021
- Primary completion15 Nov 2021
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3D Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xueying ding, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941313
- Sponsor's protocol ID
- 3D229-CN-001
- Status last verified
- Mar 2022
- First submitted
- 31 May 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and Tolerability of 3D-229 by Intravenous Single Dose Escalation and Repeated Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04941313
- Acronym / sponsor ID
- 3D229-CN-001
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- 3D MedicinesIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 28 Jun 2021 (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 Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects
Detailed description
A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 by Intravenous Single Dose Escalation(SAD) and Repeated Doses(RD) in Healthy Subjects. A SAD portion of the study consists of 2 sequential dose escalation cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses of 3D229. In both SAD and RD study arms, subjects are randomized to receive either a study intervention (3D229) or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Dose Escalation-3D229 | Experimental | Drug: 3D229two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo |
| Single Dose Escalation- placebo | Placebo comparator | Other: Placebotwo sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo |
| Repeat Dose-3D229 | Experimental | Drug: 3D229Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo |
| Repeat Dose-placebo | Placebo comparator | Other: PlaceboFour single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy subjects had no clinically significant condition or disease confirmed by medical history, medical assessment, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) at screening and on the day prior to the first study drug administration;
- Male or female, aged 18-55 years at the time of signing the informed consent form;
- Body mass index (BMI) between 18 and 30 kg/m 2 (Containing 18 and 30 kg/m 2 ) within range;
- Negative urine drug screen/alcohol breath test at screening and 1 day prior to first study drug administration;
- Has not used tobacco products (including nicotine patches/gum) within 3 months prior to screening and agrees to avoid such products throughout the study;
Key exclusion criteria (11 listed)
- Blood pressure ≥ 140/90 mmHg or pulse > 100 beats/min at rest at screening;
- QT interval corrected for heart rate using Fridericia ' s formula (QTcF) > 430 msec (males) and > 450 msec (females) at screening;
- Pregnant or lactating women;
- Males with partners in pregnancy;
- Concurrently enrolled in another clinical trial, or received any study drug within 3 months prior to the first dose (or 5 drug half-lives, whichever is longer);
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 |
|---|---|---|
| 3D2293D229 is an investigational drug. | Drug | Repeat Dose-3D229, Single Dose Escalation-3D229 |
| PlaceboMatching placebo | Other | Repeat Dose-placebo, Single Dose Escalation- placebo |
Primary outcome
Safety and tolerability of 3D229-Adverse events
Time frame: Up to 7 weeks
Monitoring of adverse events
9 secondary outcomes
AUC
Time frame: Up to 7 weeks
Cmax
Time frame: Up to 7 weeks
Ctrough
Time frame: Up to 7 weeks
Tmax
Time frame: Up to 7 weeks
λz
Time frame: Up to 7 weeks
t1/2
Time frame: Up to 3 weeks
CL
Time frame: Up to 7 weeks
V
Time frame: Up to 7 weeks
serum GAS6
Time frame: Up to 7 weeks
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 22 Jun 2022.
- Individual participant dataSharing planned: No
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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.
xueying ding principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 3D229 in people with Healthy Subject, run by 3D Medicines 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 9 inclusion and 11 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 22 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability of 3D229-Adverse events (time frame: Up to 7 weeks). 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 22 Jun 2022.