NCT03803163TerminatedPhase 1
A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of TransCon PEG Treprostinil Administered as a Subcutaneous Injection in Healthy Adult Male Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Ascendis Pharma A/S
- Enrollment
- 20
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Study Overview
Brief Summary
To determine the maximum tolerated dose (MTD) and assess safety and tolerability of escalating single doses of TransCon PEG treprostinil administered as a subcutaneous injection to healthy male volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject gives voluntary written informed consent to participate in the study.
- •Subject is a healthy male between the ages of 18 and 50 years, inclusive, at Screening.
- •Subjects must weigh between 60 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
- •Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.
- •Subject agrees to abstain from taking any prescription medication for 14 days prior to check-in and to abstain from taking any non-prescription medications (except multivitamins) or herbal supplements for 7 3 days prior to check-in Baseline until discharge from the study (unless prescribed by the Investigator to treat an AE).
- •Subject agrees to abstain from consuming alcohol from three days prior to check-in and until discharge from the study.
- •Subject agrees to refrain from strenuous exercise from check-in and until discharge from the study.
- •Subject is able to communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
Exclusion Criteria
- •Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
- •Subject has a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- •Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- •Subject has a history of postural hypotension, or unexplained syncope.
- •Subject has a blood pressure that is less than 90 mmHg systolic or 50 mmHg diastolic at Screening or Baseline.
- •Subject has a pulse rate that is greater than 90 bpm after sitting at rest for at least 5 minutes at Screening or Baseline.
- •Subject has a history of hypertension.
- •Subject has a blood pressure that is greater than 150 mmHg systolic or 90 mmHg diastolic at Screening or Baseline
- •Subject has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Subject has tested positive at the screening visit for HIV infection, HBsAg, or the HCV antibody.
- •Subject currently uses tobacco or nicotine products or has a history of tobacco use within six months prior to Baseline.
- •Subject has a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
- •Subject has a history of or current evidence of abuse of licit or illicit drugs, including a positive urine screen for drugs of abuse at Screening or Baseline.
- •Subject has a history of abnormal bleeding tendencies.
- •Subject has donated blood or plasma or has lost a significant volume of blood (greater than 450 mL) within four weeks prior to Baseline.
- •Subject has participated in any investigational drug study within 30 days prior to their initial Screening visit.
Arms & Interventions
TransCon Treprostinil
Experimental
Intervention: TransCon Treprostinil (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 42 days
Safety and tolerability of single doses of TransCon Treprostinil treatment
Secondary Outcomes
- Maximum Plasma Concentration [Cmax] of TransCon Treprostinil(42 days)
Investigators
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