A Study to Evaluate the Denosumab in Healthy Adults

NCT03427853 | Unknown Phase 1

• 1 other identifier: LY06006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to healthy adults in China

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Number of patients with treatment related adverse events

  Number of patients with treatment related adverse events assessed by change from baseline

  56 days

• Number of patients with abnormal laboratory values

  Number of patients with abnormal laboratory values assessed by change from baseline

  56 days

Secondary Outcomes (3)

• Maximum plasma concentration (Cmax)

  56 days

• Area under the Curve (AUC)

  56 days

• Number of patients with anti drug antibodies

  56 days

Study Arms (2)

LY06006

EXPERIMENTAL

LY06006 18mg, 60mg 120mg subcutaneous injection

Drug: LY06006

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection

Drug: Placebos

Interventions

LY06006 DRUG

LY06006 18mg, 60mg, 120mg subcutaneous injection

LY06006

Placebos DRUG

Placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed ICF and complied with ICF requirement and restrictions
• Healthy male and female, 18≤age≤65
• In screening visit, male body weight≥50kg，female body weight≥45kg，and 19.0≤BMI≤24.0 kg/m2；
• At screening visit: physical examination, vital signs, laboratory tests, electrocardiogram, chest X-ray examination, abdominal CT examination are normal or abnormal but no clinical significance confirmed by investigators；
• During the study period and within 12 months after the study drug administration, the subjects and partners agreed to use reliable contraceptive measures

You may not qualify if:

• Pregnant or lactating women；
• Fertility plan within one year；
• The subject has a history of hypersensitivity or allergy to LY06006 or any of its excipients；or allergy to any drug, food and pollen, or IGE test is positive.
• Subjects are suffering from or have had osteomyelitis or osteonecrosis of the Jaw, or plan to have invasive dental or maxillofacial surgery during the study, or dental or oral surgery wounds unhealed;
• Have fractures in past six months；
• Active respiratory, digestive, urinary, reproductive or skin infections；
• Have oncology family history ；
• Have mental illness history；
• In screening visit: Chest X-ray, abdominal CT indicated clinical significance，for example: tuberculosis, inflammation, et al；
• PPD test positive with 48-72 hrs induration reading≥5mm；
• Blood chemistry：ALT or AST \>1.5 ULN，Cr\>1.0 ULN；Blood routine：WBC\<0.8 LLN or\>1.2 ULN；NE\<0.8 LLN；PLT\<0.8 LLN；HGB\<0.8LLN；
• Suffering from or have had the following diseases affecting the bone metabolism: malignant tumors (including myeloma), hypoparathyroidism / hyperthyroidism, hypothyroidism, acromegaly, cushing's syndrome, hypopituitarism, severe chronic obstructive pulmonary disease, rheumatoid arthritis, osteomalacia et al;
• The medicines that may affect bone turnover are used before randomization or planned to use in the study period , including but not limited : denosumab, bisphosphonates or fluorides were used in past 12 months; contraceptives with hormone，hormone replacement therapy（tibolone、hormone、selective estrogen receptor modulators）aromatase inhibitors, calcitonin, strontium salt, parathyroid hormone (or derivative), vitamin D supplement，anabolic steroids, systemic glucocorticoids, calcitriol or analogues, diuretics, anticonvulsant drugs；inhalation or local use of glucocorticoids within 2 weeks
• Significant changes in physical activity in 6 months before randomization; or have been playing strenuous sports, or plan to play strenuous sports during the study period.
• Any of HBsAg, HCV-Ab, Anti-HIV, TP-Ab is positive；

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead
• Shandong Boan Biotechnology Co., Ltd: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Xicheng District, China

RECRUITING

Study Officials

• Huanhuan Jiang

  Shangdon Boan Biotechnology Co Ltd

  STUDY DIRECTOR

Central Study Contacts

Yi Fang, MD

CONTACT

8610-8832666; fygk7000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 9, 2018
• Study Start: January 10, 2018
• Primary Completion: December 28, 2019
• Study Completion: December 28, 2019
• Last Updated: February 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)