A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of KDF-07002 in Healthy, Adult Volunteers

Phase 1

Recruiting

• Conditions: This trial is to assess safety and tolerability of KDF-07002 in healthy adult males and dose not focus on any particular health condition or problem; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12609000086268
• Lead Sponsor: ucleus Network, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

1. Be a male between the ages of 18 and 60 years, inclusive.
2. Be healthy and have an acceptable medical history (defined as individuals who in the view of the investigator are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, infective, or psychiatric diseases and confirmed by medical history, physical examination, and laboratory tests).
3. Have readily accessible peripheral venous access sites for administration of clinical trial material and blood sampling.
4. Subjects who are sexually active must also agree to a reliable form of contraception during the study and for 30 days following administration of the study drug.
5. Have the ability to understand the requirements of the study, be willing to provide written informed consent as evidenced by signature on an informed consent document approved by the institution’s Human Research Ethics Committee (HREC), and agree to abide by the study restrictions

Exclusion Criteria

1. Have a known sensitivity to any imaging contrast agents
2. Be an intravenous drug user, user of any illicit drugs, or dependent on alcohol
3. Have participated in an investigational drug or device study within the past 30 days
4. Have donated blood or blood products within the past 30 days prior to pretreatment baseline
period.
5. Have had surgery or suffered injury involving significant blood loss within the past 45 days
prior to pretreatment baseline period.
6. Have any clinically significant abnormal laboratory test based on clinical chemistry, hepatic
profile, renal profile, hematology, or coagulation measures
7. Have epilepsy or a history of grand mal seizure
8. Have a red blood cell disorder such as hemoglobinopathies or anemia
9. Have asthma, Chronic Obstructive Pulmonary Disease, Restrictive Pulmonary Disease or any
other allergic respiratory diseases
10. Have hepatic disease (liver function tests greater than 1.5 times the upper limit of normal)
11. Have renal impairment with serum creatinine > 105 mmol/L and/or Glomerular Filtration Rate (GFR) <60 mL/min.
12. Have splenic disorders such as hepatosplenomegally, splenomegally or splenectomy
13. Have a history of pancreatitis
14. Have thrombocytopenia (<150,000 platelets/mm3)
15. Have a blood-clotting disease including hemophilia or von Willebrand disease
16. Be currently taking warfarin (Coumadin®)
17. Have a known allergy to eggs

Study & Design

• Study Type: Interventional
• Study Design: Not specified