Effect of TPN171H on Spermatogenesis

Evaluate the Acute Effects of a Single Oral Dose of TPN171H on Semen Function in Healthy Male Subjects in China

This study is a phaseⅠstudy to determine the acute effects of TPN171H on semen function in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: TPN171H 10mg; Drug: TPN171H Placebo

Detailed Description

Safety Study in male subjects

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male aged 18~40years (included)
2. Body Mass Index of 19 to 28 kg/m2; Body weight no less than 50 kg;
3. Sperm concentration ≥15*10^6/ml, Sperm motility(a+b(%))≥32%, Semen volume ≥1.5 ml, Liquefaction time≤60 min
4. Sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence.
5. Take reliable contraceptive measures
6. Physical examination, vital signs examination, laboratory examination, ECG were normal or abnormal without clinical significance;
7. Be able to understand and willing to sign the Informed Consent Form;

Exclusion Criteria:

1. People with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease
2. People with vasectomy and ligation
3. People who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;
4. There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
5. Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
6. A history of fainting needles or fainting blood;
7. Blood loss or blood donation of 400 mL or more within 3 months before administration;
8. Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration
9. those who have participated in other drug clinical trials and received trial drugs within 3 months before
10. Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
11. Urine drug screening positive；
12. Smoking more than 10 cigarettes per day ；
13. Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
14. he investigator believes that there are other factors that are not suitable for participating in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 9 subjects receive 10 mg TPN171H for Period 1; Placebo for Period 2	Drug: TPN171H 10mg; Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition.; Drug: TPN171H Placebo; Subjects were given Placebo with 240 mL warm water under fasting condition.
Experimental: Cohort 2; 9 subjects receive Placebo for Period 1; 10 mg TPN171H for Period 2	Drug: TPN171H 10mg; Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition.; Drug: TPN171H Placebo; Subjects were given Placebo with 240 mL warm water under fasting condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on semen function	The parameters of semen routine analysis were compared between TPN171H tablets and placebo.	1.5 hours after taking the medicine
Seminal plasma exposure	TPN171H exposure in seminal fluid	1.5 hours after taking the medicine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study	From administration of study drug through 3 days after last administration of study drug

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: Hui Jiang, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: September 18, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: TPN171H-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No