Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorZhuhai United Laboratories Co., Ltd.

About this trial

To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.

Eligibility criteria

Qualifiers

Participants must sign the informed consent form prior to the study, fully understand the study, procedures, and potential adverse reactions, and be voluntary participate in and able to complete the study as required by the protocol.

Male or female participants aged 18-45 years (inclusive).

Body weight of not less than 50.00 kg for male participants and 45.00 kg for female participants with body mass index (BMI) within the range of 19.0-27.0 kg/m2 (inclusive).

Female participants of childbearing potential, or male participants whose partners are of childbearing potential, must have no plans for pregnancy, sperm/egg donation from signing the informed consent until 3 months after the last dose, and must be voluntary to use highly effective contraception (including their partners) (non-pharmacological contraception is required during the study).

Disqualifiers

Having a clinically significant severe disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, pulmonary, immunological, psychiatric, or cardiovascular and cerebrovascular diseases) within 12 months prior to screening.

Participants with clinically significant abnormalities in laboratory tests, physical examination, vital signs, electrocardiogram (ECG), posteroanterior chest X-ray, or abdominal ultrasound.

Female participants who are pregnant or lactating.

Participants with acute illness or requiring concomitant medication from screening to the first dose.

Trial design

Treatments tested in this trial

  • TUL108
  • Placebo
  • TUL108

Treatment groups

72 Participants
are divided into 4 treatment groups