A single dose phase I clinical study to assess the safety, tolerance, pharmacokinetic, pharmacodynamic of ORMD-0801 gelatin soft capsule in healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039220

Enrollment

Unknown

Registered

2020-10-22

Start date

2019-08-28

Completion date

Unknown

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Test product group versus placebo group:Single dose administration, the test product group and the placebo group received either the test product or placebo. Followed up 7 days after treatment.

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Main inclusion criteria: 1. Voluntary to be tested and give written informed consent; 2. Aged 18 to 45 years; 3. BMI 18 to 26 kg/m2, male body weight >=50 kg, female body weight >= 45 kg; 4. FPG =1.0 ng/mL at screening; 6. Based on the results of physical examination, medical history, vital signs, electrocardiogram, and clinical laboratory tests, investigators believe that the subjects are in good health condition and have no clinically significant disease history of heart, liver, kidney, digestive tract, or nervous system, respiratory system, psychiatric disorder and metabolic abnormalities. No abnormalities or abnormalities without clinical significance after comprehensive physical examination, vital signs examination and laboratory examination (subject to the judgment of the clinician).

Exclusion criteria

Exclusion criteria: 1. Any history of serious clinical diseases, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases or physiological conditions that may interfere the results of the study, which are considered significant by the investigator; 2. There was diabetes patient in first-degree relatives; 3. Any examination result of surface antigen of hepatitis B(HBsAg), e antigen of hepatitis B (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV), treponema pallidus antibody (TP-Ab) is positive.

Design outcomes

Primary

Measure	Time frame
The safety of ORMD-0801 gelatin soft capsule were evaluated by vital signs, physical examination, laboratory tests, electrocardiogram, hypoglycemic events and adverse events.;	—

Countries

China

Contacts

Public ContactGuang Ning

Ruijin Hospital

guangning@medmail.com.cn+86 13918034747

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026