HealthyPhase 1NCT05984368
A Clinical Study of BG136 Injection in Healthy Chinese Volunteers
A Phase 1 study testing BG136 in people with Healthy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BG136
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2023to 6 May 2024
- 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
- Chinese male or female subjects aged 18-55 years (including the threshold);
- Weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI): 19.0-26.0 kg/m2 (including borderline values);
- Subjects understand and comply with the study process, can communicate well with the investigator, volunteer to participate in the trial and sign an informed consent form.
Who cannot join
- Diseases to be excluded due to clinical abnormalities within 3 months prior to screening, including but not limited to neurological/psychiatric, cardiovascular, hematological and lymphatic, immune, gastrointestinal, urinary, endocrine, metabolic, and skeletal conditions. History of diseases of the urinary, endocrine, respiratory, metabolic and skeletal systems.
- History of comorbid gastrointestinal related disorders
- Those who have had surgery within 3 months prior to screening or plan to have surgery during the study period；
- Screening subjects whose vital signs, physical examination, routine blood, urine, blood biochemistry, coagulation function, and electrocardiogram are judged by the investigator to be abnormal and clinically significant；
- Subject's imaging determined by the investigator to be clinically significant for abnormalities；
- Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody screening, human immunodeficiency virus (HIV) antibody screening, treponema pallidum antibody (TP-Ab) any test positive；
Show all 20Show fewer
- History of food or drug allergies or other allergic diseases；
- History of substance abuse in the 12 months prior to screening, or drug use in the 3 months prior to screening, or a positive urine drug screen；
- Positive breath test results for alcohol or regular alcohol consumption in the 6 months prior to screening, i.e., an average of more than 14 units of alcohol per week (1 unit ≈ 200 mL of beer at 5% alcohol or 25 mL of spirits at 40% alcohol or 85 mL of wine at 12% alcohol), or inability to abstain from alcohol consumption for 48 hours prior to the first dose of the medication and for the entire study period；
- Smokers who smoked an average of ≥5 cigarettes per day in the 3 months prior to screening or who could not give up smoking 48 hours prior to the first dose and throughout the study period；
- Those who have received a blood transfusion or used blood products ≥ 400 mL or 2 units within 3 months prior to screening, or those who have lost ≥ 400 mL of blood within 6 months, or those who have donated blood within 3 months；
- Participated in another clinical trial within 3 months prior to screening and took the trial drug or used the trial device；
- Any prescription (including vaccines), over-the-counter medications used within 4 weeks prior to screening；
- Those who have used herbal medicines or health supplements for the treatment and/or prevention of their own disease within 2 weeks prior to screening；
- Persons with special dietary requirements who are unable to follow a standardized diet or who are unable to avoid xanthine-rich beverages or foods or fruits or fruit juices that may interfere with metabolism for 48 hours prior to dosing and up to study completion;
- Those who have difficulty in collecting blood from veins or who suffer from needle;
- Women who are pregnant, breastfeeding, or who have had unprotected sex within 2 weeks prior to screening, or who have had a positive pre-test pregnancy test;
- Male subjects (or their partners) or female subjects who are planning a pregnancy, sperm donation, or oocyte donation from the time of signing the Informed Consent Form until 3 months after the end of the administration of the medication;
- Those who do not wish to use one of the medically approved non-pharmacological contraceptives (e.g., intrauterine device or condom) during the trial period;
- Subjects deemed unsuitable by the investigator to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Qingdao, Shandong, 266003
Yu Cao, Dr, 86-18661809090, caoyu1767@126.com
About this study
Official title: First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation and Multiple Dose Escalation Phase I Clinical Trial of BG136 for Injection in Healthy Subjects
This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)
Read the detailed description
This is a first-in-human, randomized, double-blind, placebo-controlled clinical trial in healthy subjects. The trial consists of two parts: Part 1: a single ascending dose (SAD) study with seven dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose groups), with two subjects enrolled in the 2 mg group (all receiving the test drug), and eight subjects enrolled in each of the remaining groups (six test drug and two placebo); Part 2: a multiple ascending dose (MAD) study with seven dose groups: two subjects (six test drug and two placebo); and Part III: a randomized, double-blind, placebo-controlled clinical trial in healthy subjects, with a randomized, double-blind, placebo-controlled clinical trial in healthy subjects. Part II: Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each including 8 healthy subjects (6 test drug, 2 placebo).
- Conditions
- Healthy
- Being tested
- BG136, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG136Drug
Subjects injected with BG136 in Part 1 and Part 2
PlaceboDrug
Subjects injected with Placebo in Part 1 and Part 2
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | A single ascending dose (SAD) study divided into 7 dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose group), with 2 mg enrolling 2 subjects (all receiving the test drug) and the remaining 8 subjects in each group (6 test drug, 2 placebo). Receives: Drug: BG136; Drug: Placebo |
| Part 2 | Experimental | Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each group included 8 healthy subjects (6 test drug, 2 placebo). Receives: Drug: BG136; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: up to 14 days
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: up to 14 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Measured: up to 14 days
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start18 Aug 2023
- Primary completion5 Sep 2023 (estimated)
- Study completion6 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Sequential
- Model description
- Single-dose and multi-dose, dose escalation, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
- Investigators
- Yu Cao, doctor, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984368
- Sponsor's protocol ID
- BG136211213
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 30 Aug 2023
- Results posted
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation and Multiple Dose Escalation Phase I Clinical Trial of BG136 for Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05984368
- Acronym / sponsor ID
- BG136211213
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 5 Sep 2023 (estimated)
- Study completion
- 6 May 2024 (estimated)
- First posted
- 9 Aug 2023 (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 first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)
Detailed description
This is a first-in-human, randomized, double-blind, placebo-controlled clinical trial in healthy subjects. The trial consists of two parts: Part 1: a single ascending dose (SAD) study with seven dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose groups), with two subjects enrolled in the 2 mg group (all receiving the test drug), and eight subjects enrolled in each of the remaining groups (six test drug and two placebo); Part 2: a multiple ascending dose (MAD) study with seven dose groups: two subjects (six test drug and two placebo); and Part III: a randomized, double-blind, placebo-controlled clinical trial in healthy subjects, with a randomized, double-blind, placebo-controlled clinical trial in healthy subjects. Part II: Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each including 8 healthy subjects (6 test drug, 2 placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-dose and multi-dose, dose escalation, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: BG136, Drug: PlaceboA single ascending dose (SAD) study divided into 7 dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose group), with 2 mg enrolling 2 subjects (all receiving the test drug) and the remaining 8 subjects in each group (6 test drug, 2 placebo). |
| Part 2 | Experimental | Drug: BG136, Drug: PlaceboMultiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each group included 8 healthy subjects (6 test drug, 2 placebo). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese male or female subjects aged 18-55 years (including the threshold);
- Weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI): 19.0-26.0 kg/m2 (including borderline values);
- Subjects understand and comply with the study process, can communicate well with the investigator, volunteer to participate in the trial and sign an informed consent form.
Key exclusion criteria (20 listed)
- Diseases to be excluded due to clinical abnormalities within 3 months prior to screening, including but not limited to neurological/psychiatric, cardiovascular, hematological and lymphatic, immune, gastrointestinal, urinary, endocrine, metabolic, and skeletal conditions. History of diseases of the urinary, endocrine, respiratory, metabolic and skeletal systems.
- History of comorbid gastrointestinal related disorders
- Those who have had surgery within 3 months prior to screening or plan to have surgery during the study period；
- Screening subjects whose vital signs, physical examination, routine blood, urine, blood biochemistry, coagulation function, and electrocardiogram are judged by the investigator to be abnormal and clinically significant；
- Subject's imaging determined by the investigator to be clinically significant for abnormalities；
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 |
|---|---|---|
| BG136Subjects injected with BG136 in Part 1 and Part 2 | Drug | Part 1, Part 2 |
| PlaceboSubjects injected with Placebo in Part 1 and Part 2 | Drug | Part 1, Part 2 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Peak Plasma Concentration (Cmax)
Time frame: up to 14 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: up to 14 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: up to 14 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Yu Cao, doctor principal investigator
The Affiliated Hospital of Qingdao University
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 BG136 in people with Healthy, run by The Affiliated Hospital of Qingdao University 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 3 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, doctor (86-18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: up to 14 days). The study lists 4 primary outcomes in all. 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 30 Aug 2023.