DiabetesPhase 1NCT03203811
A Phase 1, Study to Evaluate HTI-2088 Tablet
A Phase 1 study testing HTI-2088 in people with Diabetes, run by Hengrui Therapeutics, Inc. at 1 site in United States.
Trial summary
Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3 levels. Ten subjects will be enrolled at each dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- HTI-2088
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 23 Oct 2017
- 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 male or female between 18 and 55 years of age (inclusive), without diabetes FPG <126 mg/dL.
- Body mass index (BMI) of 19 to 30 kg/m2 (inclusive); and a total body weight ≥50 kg.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- An informed consent document signed and dated by the subject.
- Male subjects must agree to utilize a highly effective method of contraception (condom with or without spermicide) during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 90 days following IP dosing, and must agree to refrain from sperm donation from Day 0 until at least 90 days after the IP dose.
- Females must meet at least one of the following criteria:
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- sexually inactive (abstinent) for at least 14 days prior to the first dose, throughout the study and for 90 days after IP dose
- postmenopausal, defined by at least 12 consecutive months of amenorrhea without an alternative medical cause
- using one of the following acceptable birth control methods: surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) at least 6 months prior to the first dose; intra-uterine device in place for at least 3 months prior to the first dose; barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for 90 days after IP dose; surgical sterilization of the partner (vasectomy for at least 6 months prior to the first dose); hormonal contraception for at least 3 months prior to the first dose, throughout the study and for 90 days after IP dose.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or drug allergies. In particular, any history or evidence at Screening of chronic GI disorders (e.g., celiac sprue, ulcerative colitis, Crohn's disease, etc.), thyroid disease, or pancreatitis, any condition possibly affecting drug absorption (e.g., gastrectomy).
- History of gastrointestinal surgery within one year of the screening visit.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could have increased the risk associated with study participation or investigational product administration or could have interfered with the interpretation of study results and, in the judgment of the investigator, made the subject inappropriate for entry into the study.
- Positive results of alcohol or substances of abuse at screening or upon admission to the clinical research unit.
- A positive pregnancy test at screening and upon admission to the clinical research unit, or subject is lactating, if the subject is female.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounce (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening; Consumption of alcohol within 24 hours of receiving IP.
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- Treatment with any investigational drug within 30 days or 5 half-lives preceding the first dose of IP.
- Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
- Blood donation of approximately 1 pint (approximately 473 mL) or more within 56 days, or plasma donation within 7 days of receiving IP.
- Use of prescription, nonprescription drugs, illicit drug use, and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of IP. Herbal supplements and hormone replacement therapy should be discontinued 28 days prior to the first dose of IP.
- Evidence of human immunodeficiency virus (HIV)/ hepatitis C/ hepatitis B infection and/or positive human HIV/hepatitis C/hepatitis B antibodies (a negative test result within the 3 months prior to screening may be used instead of obtaining a screening laboratory sample for these laboratory tests)
- History of using GLP-1 analogs.
- Known sensitivity to any of the components of the investigational product formulation or SNAC
- Current smoker or user of any tobacco products.
- Consumption of any grapefruit or grapefruit-containing juices within 14 days of receiving the IP.
- Consumption of any caffeine- or xanthine-containing foods or beverages within 24 hours of receiving IP.
- Have poor venous access and are unable to donate blood.
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
- Subjects who are investigational site staff members or subjects who are Sponsor employees directly involved in the conduct of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Placebo-Controlled, Single Oral Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTI-2088 Tablet in Healthy Adult Subjects
Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3 levels. Ten subjects will be enrolled at each dose.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose trial with single oral doses of HTI-2088 tablets to subjects at 3 levels (2.5, 3.75, 5 mg). Ten subjects will be enrolled at each dose level, randomized within groups at an active: placebo ratio of 4:1.
- Conditions
- Diabetes
- Being tested
- HTI-2088, Placebo
- Keywords
- Healthy Subjects
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTI-2088Drug
3 dose levels
PlaceboDrug
placebo oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 2mg, HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days Receives: Drug: HTI-2088; Drug: Placebo |
| Middle Dose | Experimental | 3.75mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days Receives: Drug: HTI-2088; Drug: Placebo |
| High Dose | Experimental | 5mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days Receives: Drug: HTI-2088; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 week
Cmax
Peak Plasma Concentration (Cmax)
Measured: 1 week
AUC
Area under the plasma concentration versus time curve (AUC)
Measured: 1 Week
Secondary outcomes (3)
PD Effects
effects on Glucose, Insulin, Insulin C-peptide
Measured: 1 week
Glucose
Number of patients with effects on Glucose, Insulin, Insulin C-peptide
Measured: 1 week
Insulin
Number of patients with effects on Insulin and Insulin C-peptide
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start17 Feb 2017
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hengrui Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203811
- Sponsor's protocol ID
- HTI-2088-101
- Status last verified
- Nov 2017
- First submitted
- 12 Jun 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-Controlled, Single Oral Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTI-2088 Tablet in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03203811
- Acronym / sponsor ID
- HTI-2088-101
- Conditions
- Diabetes
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hengrui Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 29 Jun 2017 (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.
Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3 levels. Ten subjects will be enrolled at each dose.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose trial with single oral doses of HTI-2088 tablets to subjects at 3 levels (2.5, 3.75, 5 mg). Ten subjects will be enrolled at each dose level, randomized within groups at an active: placebo ratio of 4:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: HTI-2088, Drug: Placebo2mg, HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days |
| Middle Dose | Experimental | Drug: HTI-2088, Drug: Placebo3.75mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days |
| High Dose | Experimental | Drug: HTI-2088, Drug: Placebo5mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female between 18 and 55 years of age (inclusive), without diabetes FPG <126 mg/dL.
- Body mass index (BMI) of 19 to 30 kg/m2 (inclusive); and a total body weight ≥50 kg.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- An informed consent document signed and dated by the subject.
- Male subjects must agree to utilize a highly effective method of contraception (condom with or without spermicide) during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 90 days following IP dosing, and must agree to refrain from sperm donation from Day 0 until at least 90 days after the IP dose.
Key exclusion criteria (19 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or drug allergies. In particular, any history or evidence at Screening of chronic GI disorders (e.g., celiac sprue, ulcerative colitis, Crohn's disease, etc.), thyroid disease, or pancreatitis, any condition possibly affecting drug absorption (e.g., gastrectomy).
- History of gastrointestinal surgery within one year of the screening visit.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could have increased the risk associated with study participation or investigational product administration or could have interfered with the interpretation of study results and, in the judgment of the investigator, made the subject inappropriate for entry into the study.
- Positive results of alcohol or substances of abuse at screening or upon admission to the clinical research unit.
- A positive pregnancy test at screening and upon admission to the clinical research unit, or subject is lactating, if the subject is female.
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 |
|---|---|---|
| HTI-20883 dose levels | Drug | High Dose, Low Dose, Middle Dose |
| Placeboplacebo oral tablet | Drug | High Dose, Low Dose, Middle Dose |
Primary outcome
Adverse Events
Time frame: 1 week
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Cmax
Time frame: 1 week
Peak Plasma Concentration (Cmax)
AUC
Time frame: 1 Week
Area under the plasma concentration versus time curve (AUC)
3 secondary outcomes
PD Effects
Time frame: 1 week
Glucose
Time frame: 1 week
Insulin
Time frame: 1 week
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 14 Nov 2017.
- 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.
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 HTI-2088 in people with Diabetes, run by Hengrui Therapeutics, Inc. at 1 site in United States.
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 19 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 14 Nov 2017. 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 United States. 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?
Adverse Events (time frame: 1 week). The study lists 3 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 14 Nov 2017.