Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Healthy Subjects.

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Renal Anemia

Treatments: Drug: DDO-3055 tablets；Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04775615

DDO-3055-105

Details and patient eligibility

About

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy volunteers aged 18-45 years;
2. Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2;
3. Signed informed consent.

Exclusion criteria

1. Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
2. A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, Total bilirubin, direct bilirubin, indirect bilirubin ；
3. Subjects with a value at screening is greater than the upper limit of reference range for serum creatinine;
4. Subjects with a positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；
5. Subjects with blood loss ≥400mL within 3 months before screening;
6. Subjects has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study.
7. Participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;
8. Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening.
9. Smokers (average daily smoking 5 or more); Subjects who consumed more than 15 grams of alcohol per day within one week prior to the screening;
10. Drug abusers or drug urine screening positive;
11. The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

Treatment group A

Experimental group

Treatment:

Drug: DDO-3055 tablets；Placebo

Drug: DDO-3055 tablets；Placebo

Drug: DDO-3055 tablets；Placebo

Treatment group B

Experimental group

Treatment:

Drug: DDO-3055 tablets；Placebo

Drug: DDO-3055 tablets；Placebo

Drug: DDO-3055 tablets；Placebo

Treatment group C

Experimental group

Treatment:

Drug: DDO-3055 tablets；Placebo

Drug: DDO-3055 tablets；Placebo

Drug: DDO-3055 tablets；Placebo